Herbal Therapy for Treatment of Recurrent Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy

Status Completed

Clinical Trial Summary

This study is about Prostate Health Cocktail, a combination supplement that contains vitamin D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This product is currently available on the market, as herb and vitamin supplements are not regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in patients with prostate cancer. At the doses included in this supplement, no serious side effects have been reported.

The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA. Additionally, we will be looking to see whether taking this treatment causes any unexpected side effects, and whether certain blood tests can inform us about your disease status in addition to your PSA

Clinical Trial Description

Objectives of this study are:

• To assess the PSA response in prostate cancer patients who have a PSA-only disease recurrence after curative local therapy, during treatment with a combination herbal supplement.

• To qualitatively and quantitatively describe the toxicity profile of this herbal supplement.

• To assess changes in PSA doubling time for subjects treated with this supplement.

• To measure tissue GRP78, serum neuroendocrine markers, and circulating tumor cells, for correlation with treatment response and prostate cancer outcomes ;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00669656
• Study type: Interventional
• Source: University of Southern California
• Status: Completed
• Phase: Phase 2
• Start date: July 6, 2008
• Completion date: October 14, 2014